Prealbumin, Fitc, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting prealbumin (transthyretin) using FITC as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based measurement of this negative acute-phase protein used as a sensitive indicator of nutritional status and hepatic protein synthesis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is DDS, regulated under 21 CFR 866.5060, within the Immunology specialty.
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Basic Information
- Product Code
- DDS
- Device Class
- FDA class 1
- Regulation Number
- 866.5060
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972812 | RAICHEM PREALBUMIN SPIA | Aug 28, 1997 | Substantially Equivalent | Hemagen Diagnostics, Inc. |
| K964781 | IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT | May 09, 1997 | Substantially Equivalent | Beckman Instruments, Inc. |
| K934966 | SPQ PAL CONTROL LEVEL II | Jan 11, 1994 | Substantially Equivalent | Incstar Corp. |
| K854811 | ICS PAB PREALBUMIN REAGENT TEST KIT | Jan 24, 1986 | Substantially Equivalent | Beckman Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.